BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132393 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30551
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE WOKEN UP WITH HIGH BLOOD GLUCOSE OF 450 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER RECEIVED NEW INSULIN PUMP AND WAS ATTEMPTING TO PROGRAM IT. TROUBLESHOOTING WAS PERFORMED ON INSULIN PUMP. CUSTOMER DID NOT HAVE TUBING CLAMP, SO TROUBLESHOOTING COULD NOT BE CONTINUED. CUSTOMER REPORTS TO HAVE CHANGED INFUSION SET. CUSTOMER WAS ADVISED TO MONITOR BLOOD GLUCOSE AFTER INFUSION SET CHANGE SINCE BLOOD GLUCOSE HAD LOWERED TO 300 MG/DL BY THE END OF CALL. NO FURTHER INFORMATION PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612996 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR